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OpenTrials
Completed

NCT Number: NCT00592202

Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UIMC

Chicago, Illinois, 60612, United States

About this study

The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 14 through 17
  • BMI greater than 40
  • BMI 35 to 40 and also having an obesity related comorbidity
  • Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training

Exclusion criteria

  • Subject history of congenital or acquired anomalies fo the gastrointestinal tract
  • Severe cardiopulmonary or other serious organic disease
  • Severe coagulopathy
  • Hepatic insufficiency or cirrhosis
  • History of bariatric gastric or esophageal surgery
  • History of intestinal obstruction or adhesive peritonitis
  • History of esophageal motility disorders
  • Type I diabetes

Treatment and study plan

Placement of an adjustable gastric band

Device

Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.

Primary outcomes

  1. Weight loss

    Time frame: Every six months

Secondary outcomes

  1. Resolution of comorbidities

    Time frame: every six months

  2. Assess the status of comorbidities and changes in quality of life scores from baseline.

    Time frame: every six months

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2004
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2008
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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